Vasa Therapeutics Granted FDA Fast Track Designation for VS-041, a Novel Investigational Treatment of Heart Failure with Preserved Ejection Fraction (HFpEF)

• Designation underscores the potential for VS-041 to address a significant unmet medical need and potentially improve diagnosis by utilizing a serum biomarker
• VS-041 is being evaluated in a Phase 1c study of participants with HFpEF and elevated serum endotrophin

ENCINITAS, Calif., and WROCLAW, Poland, Nov. 18, 2025 /PRNewswire/ -- Vasa Therapeutics ("Vasa"), a private, clinical stage biotechnology company developing novel therapies for cardiovascular and metabolic aging, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its lead investigational therapy, VS-041, a narrow spectrum small molecule inhibitor of matrix metalloproteinases (MMPs) for the treatment of heart failure with preserved ejection fraction (HFpEF). Fast Track designation is designed to facilitate the development and expedite the review of therapies intended to treat serious conditions with unmet medical needs.

"We are extremely pleased that the FDA has granted Fast Track designation for VS-041," said Noreen R. Henig, MD, Chief Medical Officer of Vasa Therapeutics. "This designation reinforces the potential of VS-041 to address a serious unmet medical need with a novel mechanism of action that targets the underlying pathophysiology of HFpEF.  It also supports the opportunity to establish a precision medicine paradigm in diagnosis and treatment of HFpEF by utilizing an emerging biomarker. We look forward to working closely with the FDA as we advance VS-041 through clinical development."

VS-041 is an oral small molecule inhibitor of MMP-2 and -9 with a demonstrated ability to ameliorate the underlying fibroinflammation in preclinical models of HFpEF.  In a Phase 1 clinical trial completed earlier this year, VS-041 was safe and well-tolerated in healthy participants at doses commensurate with efficacy.  On October 10, 2025, the FDA cleared an Investigational New Drug application for a Phase 1c (Proof-of-Mechanism) study to assess the safety and tolerability of VS-041 in HFpEF participants (NCT07219511). The Phase 1c study is the first clinical trial focused on a subpopulation of the high-risk HFpEF patients identified by an elevated level of serum endotrophin, a biomarker of poor clinical outcomes. The Fast Track designation allows Vasa the opportunity for more frequent communication with the FDA, eligibility for rolling submission of its future New Drug Application (NDA and the potential for priority review once relevant criteria are met.  

"The Fast Track Designation for VS-041 treatment of HFpEF marks a significant milestone in our mission to advance a pipeline of drug candidates to address unmet medical needs in large groups of patients, capping off a year of strong execution," added Artur Plonowski, MD, PhD, Chief Executive Officer and co-founder of Vasa Therapeutics.  "We are currently on track to have two assets in clinical development in 2026. I want to thank the entire Vasa team for putting their hearts and science into advancing innovative therapies for cardiovascular and skeletal muscle diseases."

About VS-041

VS-041 is an oral compound that was discovered and developed by Vasa for the potential treatment of HFpEF and other chronic diseases characterized by fibroinflammation, such as hypertrophic cardiomyopathy and chronic kidney disease.  Development of VS- 041 was co-funded by the European Regional Development Fund and the Polish National Centre for Research and Development (POIR.01.01.01-00-1210/10-01).

About Heart Failure with Preserved Ejection Fraction (HFpEF)

HFpEF is a complex and progressive form of heart failure characterized by stiffening and fibroinflammation of the heart muscle and impaired relaxation despite normal contractile function. HFpEF affects ~3 million individuals in the US and ~10 million globally. Currently approved therapies for HFpEF provide clinical improvement but do not result in disease modification and durable improvement upon discontinuation of the treatment.

About Vasa Therapeutics

Vasa Therapeutics is a clinical-stage biopharmaceutical company developing novel therapeutics that target the pathophysiology of cardiovascular and muscle aging.  The company has developed a pipeline of four unique assets targeting unmet medical needs in heart failure, sarcopenia, rare neuromuscular diseases, peripheral arterial disease and life-threatening arrhythmias.

In addition to the lead program VS-041, Vasa developed a library of long-acting apelin programs targeting rare neuromuscular diseases, peripheral artery disease (PAD) and sarcopenia that have shown the potential to preserve muscle function, increase cardiac output and reverse age-related sarcopenia in preclinical models.  Vasa's long-acting apelin analog VS-214 will begin clinical testing in 2026. For more information, please visit vasatherapeutics.com

SOURCE Vasa Therapeutics